Integrated surgical staple retainer for a full thickness resectioning device

ABSTRACT

The present invention is directed to a full-thickness resection system comprising a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism includes an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another. A position adjusting mechanism is provided for moving the anvil and the stapling head relative to one another. 
     An integrated surgical retainer for use in the full thickness resectioning device is described. The integrated surgical staple retainer comprises a calibrating portion, a retaining portion, and a grasping portion. The calibrating portion defines a circular opening which has a diameter substantially equal to a diameter of a working channel of the full thickness resectioning device. The retaining portion has a lower surface adapted to limit movement of the surgical staples in the full thickness resectioning device and is adjacent to the calibrating portion of the integrated surgical staple retainer.

RELATED APPLICATIONS

This application is a continuation of prior U.S. patent application Ser.No. 10/371,437 filed Feb. 21, 2003 now U.S. Pat. No. 6,695,198, entitled“Integrated Surgical Staple Retainer for a Full Thickness ResectioningDevice” which is a continuation of U.S. patent application Ser. No.09/835,480 filed Apr. 17, 2001 now U.S. Pat. No. 6,585,144, which is aContinuation-In-Part of U.S. Ser. No. 09/694,894 filed Oct. 25, 2000 nowU.S. Pat. No. 6,241,140 which is a Continuation of U.S. Ser. No.09/316,674 filed May 21, 1999 now U.S. Pat. No. 6,179,195 which is adivision of U.S. Ser. No. 09/100,393 filed Jun. 19, 1998 now U.S. Pat.No. 6,126,058 entitled “Method and device for Full ThicknessResectioning of an Organ. All applications are expressly incorporatedherein, in their entirety, by reference.

FIELD OF INVENTION

The present invention relates to full thickness resection devices(FTRD's) for performing localized resections of lesions in tubularorgans, particularly the colon.

BACKGROUND INFORMATION

A resection procedure involves excising a portion of an organ,approximating the surrounding tissue together to close up the holecreated by the excision, and removing the excess tissue. Variousconventional devices and procedures are available for resectioninglesions in tubular organs.

For example, several known resection devices and procedures requires atleast one incision in an area near the portion of the organ to beexcised for access to the lesion or treatment site (because, forexample, the resectioning device may lack steering and/or viewingcapabilities). Thus, the incision is required to allow the physician toaccess the organ section to be excised and guide the device to thatsection. Alternatively, when the organ section to be excised is beyondthe reach of the surgical device, or the surgical device is not flexibleenough to wind through the organ to the site to be excised, an incisionwill be required to position the device for the procedure. Of course,these incisions are painful and may involve a partial or entire loss ofmobility while recuperating from the incision, in addition to recoveringfrom the tubular resectioning procedure itself. In addition, the timerequired to recover from such a procedure is often longer than forprocedures which do not require incisions.

One type of conventional resection procedure utilizes a circularstapling instrument in which a tubular section of a tubular organ isexcised, resulting in the tubular organ being separated into a firstsegment and a second segment. The end sections of the first and secondsegments are then individually tied in a purse string fashion,approximated, stapled, and the “purse stringed” end sections are thencut off. In this full circle resectioning procedure, at least oneseparate invasive incision must be made near the section to be excisedin order to cut and individually tie the separate end sections of theorgan. Also, a separate incision is necessary to place one part of theresectioning device in the first segment and a corresponding second partof the device in the second segment so that the device can then bringthe first and second segments together to re-attach the organ sectionsback together. A first of these separate parts may generally include astaple firing mechanism while the second part includes an anvil forforming the staples. Thus, this type of resectioning procedure involvesthe drawbacks mentioned above in regard to procedures requiring invasiveincisions. In addition, the separation of the organ into two segmentscreates the risk of spillage of non-sterile bowel contents into thesterile body cavity, which can cause severe infection and possiblydeath.

An alternative resectioning device includes a stapling and cuttingassembly on a shaft which can be bent or formed into a desired shape andthen inserted into a patient's body cavity. Once the shaft has been bentinto the desired shape, the rigidity of the shaft ensures that shape ismaintained throughout the operation. This arrangement limits theeffective operating range of the device as the bending of the shaft intothe desired shape before insertion and the rigidity of the shaft oncebent require the physician to ascertain the location of the organsection to be removed before insertion, and to deform the shaftaccordingly. Furthermore, the rigidity of the shaft makes it difficultto reach remote areas in the organ—particularly those areas which mustbe reached by a winding and/or circuitous route (e.g., sigmoid colon).Thus, an incision may be required near the organ section to be excisedin order to position the device at the organ section to be excised.

In addition, conventional stapling devices include staple retainerswhich serve only a limited function. Conventional staple retainers whichaccompany stapling devices are generally intended to only secure thestaples during shipment. This can be problematic as the surgeon has touse a separate instrument to gauge the diameter of an endoscope toensure the endoscope is not too large to fit through the working channelof the resectioning device. The separate endoscope gauge could easily belost during unpacking of the resectioning device since it is notattached to the device. In addition, there is an additional cost inmanufacturing a separate endoscope gauge. There is thus a need for anintegrated staple retainer which is capable of securing staples andgauging an endoscope and which can be placed within a resectioningdevice.

The full thickness resectioning device presents a unique challenge withthe need to introduce a flexible endoscope through an internal lumen ofthe device. Flexible endoscopes are manufactured and repaired bynumerous entities with little regard for standardization of maximumouter specification. The cost of repairing a damaged endoscope is highand the attempted forced introduction of a flexible endoscope into thefull thickness resectioning device will damage the endoscope. There is,therefore, a strong need for a means of insuring that only endoscopes ofan appropriate diameter are utilized.

SUMMARY OF THE INVENTION

The present invention is directed to a full-thickness resection systemcomprising a flexible endoscope and a stapling mechanism, wherein theendoscope is slidably received through at least a portion of thestapling mechanism. The stapling mechanism includes an anvil and astapling head mounted to the anvil so that the anvil and the staplinghead are moveable with respect to one another between a tissue receivingposition and a stapling position and wherein a gap formed between thestapling head and the anvil is larger in the tissue receiving positionthan it is in the stapling position. A position adjusting mechanism isprovided for moving the anvil and the stapling head between the tissuereceiving and stapling positions and a staple firing mechanismsequentially fires a plurality of staples from the stapling head acrossthe gap against the anvil and through any tissue received in the gap anda knife cuts a portion of tissue received within the gap. A control unitwhich remains outside the body is coupled to the stapling mechanism forcontrolling operation of the position adjusting mechanism and the staplefiring mechanism. An integrated surgical staple retainer and endoscopediameter gauge is provided to retain the staples in place duringshipping of the FTRD, and to allow the user to conveniently check thatthe endoscope will fit through the FTRD.

In an exemplary embodiment, the current invention is directed to anintegrated surgical staple retainer for use in a full thicknessresectioning device. The integrated surgical staple retainer comprises acalibrating portion and a retaining portion. The calibrating portiondefines a circular opening which has a diameter substantially equal to adiameter of a working channel of the full thickness resectioning device.The retaining portion has a surface adapted to limit movement of thesurgical staples in the full thickness resectioning device. Theretaining portion is adjacent to the calibrating portion of theintegrated surgical staple retainer.

A different aspect of the current invention is directed to a method ofgauging the outermost diameter of an endoscope for use in an integratedsurgical staple retainer. The calibrating portion is removed from theFTRD and is slid over the outermost diameter of the endoscope.

Another aspect of the current invention is directed to a method ofretaining staples in a full thickness resectioning device using anintegrated surgical staple retainer. The retaining portion is placedbetween a proximal housing and an anvil member of a full thicknessresectioning device. The distance between these two sections of theresectioning device is then minimized so that the integrated surgicalstaple retainer remains in position relative to the resectioning device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device according to a first embodiment of the presentinvention;

FIG. 2 shows the device of FIG. 1 mounted on a conventional endoscope;

FIG. 3 shows the device of FIG. 1 with a grasper mechanism extendingtherefrom;

FIG. 4 shows a cutaway of the device of FIG. 1 showing a drive mechanismthereof;

FIG. 5 shows a cutaway of the device of FIG. 1 showing an actuatingmechanism;

FIG. 6 shows a detailed view of the wedge used in the actuatingmechanism of FIG. 5;

FIG. 7 shows a cut-away view of a working head assembly of the device ofFIG. 1;

FIG. 8 shows a rear cover plate of the working head assembly of FIG. 7;

FIG. 9 a shows a mechanism for restricting motion of a drive shaft ofthe device of FIG. 1;

FIG. 9 b shows a first coupling arrangement for a drive cable and adrive shaft in the device of FIG. 1;

FIG. 9 c shows a second coupling arrangement for the drive cable and thedrive shaft in the device of FIG. 1;

FIG. 9 d shows a perspective cut-away view of a sheath of the device ofFIG. 1;

FIG. 10 a shows a perspective view of an alternative construction of thewedge of FIG. 6;

FIG. 10 b shows a cut-away view of the wedge of FIG. 10 a;

FIG. 10 c shows a blade portion corresponding to the wedge of FIG. 10 a;

FIG. 11 shows a device according to a second embodiment of the presentinvention;

FIG. 12 shows a device according to a third embodiment of the presentinvention;

FIG. 13 shows a device according to a fourth embodiment of the presentinvention;

FIG. 14 a shows a device according to a fifth embodiment of the presentinvention;

FIG. 14 b shows a detailed cut-away view of the device of FIG. 14 a anda conventional endoscope;

FIG. 15 shows a control handle for use with the devices according to thepresent invention;

FIG. 16 shows a blade housing arrangement for use with a deviceaccording to the present invention;

FIG. 17 shows a first arrangement of a blade shield for use with adevice according to the present invention;

FIG. 18 shows a second arrangement of the blade shield for use with adevice according to the present invention;

FIG. 19 a shows a third arrangement of the blade shield for use with adevice according to the present invention;

FIG. 19 b shows a tissue blocker of the blade shield of FIG. 19 a;

FIG. 19 c shows a distal end of a proximal housing of the device of FIG.19 a; and

FIG. 20 shows a device according to a sixth embodiment of the presentinvention.

FIG. 21 shows a device according to a seventh embodiment of the presentinvention.

FIG. 22 shows a first perspective view of the device of FIG. 21.

FIG. 23 shows a second perspective view of the device of FIG. 21.

FIG. 23 a shows a third perspective view of the device of FIG. 21.

FIG. 24 shows a side cut-away view of the device of FIG. 21.

FIG. 25 shows a fourth perspective view of the device of FIG. 21.

FIG. 26 shows a cut-away view of an exemplary stapler member of thedevice of FIG. 1.

FIG. 27 shows a perspective view of an integrated surgical stapleretainer according to a first embodiment of the present invention

FIG. 28 shows a perspective view of an integrated surgical stapleretainer according to a second embodiment of the present invention.

FIG. 29 shows a perspective view of an integrated surgical stapleretainer in relation to a full thickness resectioning device accordingto an embodiment of the present invention.

FIG. 30 shows a perspective view of an integrated surgical stapleretainer placed within a full thickness resectioning device according toan embodiment of the present invention.

FIG. 31 shows a perspective view of a calibrating portion of anintegrated surgical staple retainer gauging the outermost diameter of anendoscope according to an embodiment of the present invention.

DETAILED DESCRIPTION

As shown in FIGS. 1 and 2, an apparatus according to a first embodimentof the present invention comprises a working head assembly 2 which maypreferably be connected to a distal end 4 a of a sheath 4. The proximalend 4 b of the sheath 4 may preferably be connected to a control handle6.

In operation, the entire apparatus is mounted onto an endoscope 8 bypassing the endoscope 8 through the control handle 6, the sheath 4, andthe working head assembly 2, as shown in FIG. 2. The endoscope 8 is theninserted into a body orifice to locate a lesion in the tubular organunder visual observation (usually while insufflating the organ). Oncethe lesion has been located, the working head assembly 2 and the sheath4 are slidably advanced along the endoscope 8 into the tubular organuntil the working head assembly 2 is in a desired position adjacent tothe lesion. Those skilled in the art will understand that in analternative embodiment, the working head assembly 2 may also bedetachably coupled to a distal end of the endoscope 8, and the entirearrangement may then be inserted into the body orifice under visualobservation.

As shown in FIG. 1, the working head assembly 2 comprises an anvilmember 10 coupled to a distal end 12 a of a proximal housing 12. Theanvil member 10 has a substantially crescent-shaped cross-section (i.e.,the outer edge 18 of the anvil member 10 substantially forms a portionof a first circle with a second smaller circular cut-out 13 formedwithin the first circle) with a proximal face 14 and a smaller distalface 16. The cut-out 13 of the anvil member 10 is included to allow theendoscope 8 to be slid through the entire working head assembly 2 sothat the endoscope 8 may be advanced into the body passage allowing theworking head assembly 2 to later be advanced into the body to thelesion. In addition, the cut-out 13 also provides forward vision via theendoscope 8. Thus, any shape of the cut-out 13 may be selected which islarge enough to accommodate the endoscope 8, with a larger cut-outproviding a larger field of vision. An outer surface 18 of the anvilmember 10 extends substantially parallel to a central axis of theworking head assembly 2 while the proximal and distal faces 14, 18 ofthe anvil member 10 extend in planes substantially perpendicular to thecentral axis. The outer surface 18 is joined to the distal face 16 by atapered portion 5.

As shown in FIG. 3, the proximal face 14 of the anvil member 10 includesa first cavity 37 and a rim 41 encircling the first cavity 37. Aplurality of staple forming grooves 19 are arranged in two offset rowson the rim 41 of the anvil member 10 and a circular guiding slit 21extends radially within the rows of grooves 19. The rim 41 protrudesfrom the remainder of the proximal face 14 so that a shallow cavity isformed on the proximal face 14.

The anvil member 10 is coupled to the proximal housing 12 by means oftwo mounting shafts 20 a and 20 b, which may preferably be substantiallycylindrical. Each mounting shaft 20 a, 20 b is coupled to the proximalface 14 of the anvil member 10 on a respective one of two horns 22 a, 22b formed by the crescent-shaped anvil member 10. Although the anvilmember 10 is shown fixedly coupled to the mounting shafts 20 a, 20 b,those skilled in the art will understand that the anvil member 10 mayalso be pivotally coupled to the mounting shafts 20 a, 20 b in order toprovide a greater field of vision through the endoscope 8 as shown inFIG. 3 a. In this pivoted-type arrangement, the anvil member 10 isangled in a first configuration so that the horns 22 a, 22 b are closerto the distal end 12 a of the proximal housing than the rest of theanvil member 10. Then, as the anvil member 10 is drawn towards thedistal end 12 a of the proximal housing 12, the anvil member 10 would bepressed against the distal end 12 a beginning with the horns 22 a, 22 b,which would cause the anvil member 10 to pivot until the proximal face14 of the anvil member 10 is parallel to the distal end 12 a.

As shown in FIG. 1, the mounting shafts 20 a, 20 b are slidably receivedin mounting holes 26 a, 26 b, which have a size and shape substantiallycorresponding to the size and shape of the mounting shafts 20 a, 20 band which run axially through the proximal housing 12. The mountingshafts 20 a, 20 b are preferably movable axially proximally and distallywithin the mounting holes 26 a, 26 b between a proximal most position inwhich a tissue gripping gap of a first predetermined width is formedbetween the rim 41 and the distal end 12 a of the proximal housing 12,and a distal most position in which a tissue receiving gap of a largersecond predetermined width is formed between the rim 41 and the distalend 12 a of the proximal housing 12. The second predetermined widthshould preferably be more than twice the thickness of a wall of theorgan being resectioned so that a section of the tubular organ may bepulled into a resectioning position between the anvil member 10 and theproximal housing 12.

As shown in FIG. 4, the proximal end of at least one of the mountingshafts 20 a and 20 b is coupled to a drive mechanism 102 provided withinthe proximal housing 12. In a preferred embodiment, the drive mechanism102 is composed of a yoke 103 and a drive shaft 105. The yoke 103 ispreferably slidably received within the proximal housing 12 forlongitudinal movement along the axis of the proximal housing 12 so that,when the anvil member 10 is in the proximal most position, the yoke 103is in a corresponding proximal most position and, when the anvil memberis in the distal most position, the yoke 103 is in a correspondingdistal most position.

The yoke 103 may preferably be substantially semicircular with asubstantially rectangular cross section. Although the semicircle formedby the yoke 103 in FIG. 4 forms substantially a quarter arc of a circle,the yoke 103 may form a larger semicircle based upon the interioraccommodations of the proximal housing 12 and the position of themounting shafts 20 a, 20 b. The mounting shaft 20 a may preferably becoupled to the yoke 103 at a first end 103 a of the yoke 103, and themounting shaft 20 b may be coupled at a second end 103 b of the yoke103. A shaft hole 107, having a diameter substantially corresponding toa diameter of a complementarily threaded distal end 105 a of the driveshaft 105, extends through the yoke 103 at a point substantially midwaybetween the first end 103 a and second end 103 b. Thus, when the driveshaft 105 is rotated, the threaded distal end 105 a engages the shafthole 107 to move the yoke 103 proximally or distally (in dependence uponthe direction of rotation of the drive shaft 105).

The distal end 105 a of the drive shaft 105 should preferably bethreaded over a first section 105 t substantially corresponding inlength to at least the distance between the proximal and distal mostyoke positions, while a remainder portion 105 r may have no threadsthereon. The drive shaft 105 may have an increased cross-section in theareas immediately adjacent to the threaded first section 105 t(proximally and/or distally of section 105 t), thereby limiting themovement of the yoke 103 to the first section 105 t. Those skilled inthe art will understand that the drive shaft 105 is preferably rotatablymounted within the proximal housing 12 so that it may only rotated andmay not move relative to the proximal housing 12. The drive shaft 105preferably extends to a proximal end 105 b which is coupled to a drivecable 100 which extends to the control handle 6 through the sheath 4.The drive cable 100 may preferably run axially along the peripheralinterior of the sheath 4. Those skilled in the art will understand thatthe sheath 4 is preferably torsionally stiff to resist the torque forcesfrom the drive cables rotating therein. However, the sheath 4 islongitudinally flexible to so that it may be slidably advanced along theendoscope 8, while minimizing interference with the operation of theendoscope 8 and trauma to surrounding tissue. The sheath 4 is preferablyconstructed similar to known endoscope insertion tubes, which areflexible yet allow the transfer of forces to swivel the distal end ofthe endoscope 8 in multiple directions and the torqueable rotation ofthe endoscope.

FIGS. 7-10 show a cutaway view of the working head assembly 2 in FIG. 1,in which the respective movements of the drive shaft 105 and the yoke103 are restricted in the manner described above. As shown in FIG. 8, apearshaped rear cover plate 460 may preferably be connected to theproximal end 12 b of the proximal housing 12. A first shaft hole 462having a cross-sectional size substantially corresponding to thecross-sectional size of the drive shaft 105 is provided in a lowerportion of the rear cover plate 460 for receiving the drive shaft 105therethrough. Thus, the yoke 103 is restricted to only longitudinalmovement in this arrangement because, the distal side of the yoke 103 iscoupled to the mounting shafts 20 a, 20 b which are disposed in themounting holes 26 a, 26 b, and the proximal side of the yoke 103 iscoupled to the drive shaft 105 which is disposed in the first shaft hole462.

As shown in FIG. 9 a, the movement of the drive shaft 105 may berestricted to only rotation movement about its axis by two washer-typedevices 470 fixedly attached to the drive shaft 105 on either side ofthe rear cover plate 460. A similar result may be achieved by providingthe drive shaft 105 with a larger cross-sectional size on either side ofthe rear cover plate 460 in relation to the portion of the drive shaft105 within the rear cover plate 460. Alternatively, the cross section ofa bulging portion 476 of the drive shaft 105 located substantially inthe center of the rear cover plate 460 may be larger than the portionsof the drive shaft 105 immediately adjacent to the bulging portion 476.The first shaft hole 462 may then have a center portion 474 with alarger cross-section than the rest of the first shaft hole 462 toaccommodate the bulging portion 476 of the drive shaft 105.

FIG. 9 b shows a coupling arrangement between the drive cable 100 andthe drive shaft 105 in which a proximal end 105 a of the shaft may havea D-shaped hole 105 h extending therethrough. A distal end 102 b of thedrive cable 100 has a D-shape corresponding to the shape of the hole 105h so that the distal end 102 b of the drive cable may be received withinthe hole 105 h in the drive shaft 105. FIG. 9 c shows an alternativecoupling arrangement for coupling the drive cable 100 to the drive shaft105 in which the hole 105 h in the proximal end 105 a of the drive shaft105 a and the distal end 102 b of the drive cable 100 have correspondingsquarish shapes. The single edge provided by the D-shapes in FIG. 9 band the four edges provided by the squarish shapes in FIG. 9 c allow thedrive cable 100 to transfer a rotational force to the drive shaft 105with minimal slippage.

In operation, the user advances the endoscope 8, with the working headassembly 2 received there around, to a portion of tissue to beresectioned until the working head assembly 2 is in a desired positionadjacent to the tissue to be resectioned. The user may then apply aforce to the control handle 6 to rotate the drive cable 100 which inturn rotates the drive shaft 105 to advance the yoke 103 and the anvilmember 10 distally away from the distal end 12 a of the proximal housing12. As shown in FIG. 3 when the anvil member 10 has reached the distalmost position, a known grasping device 108 is advanced through thesheath 4 and through the working head assembly 2 to enter the gapbetween the anvil member 10 and the distal end 12 a via one of thegrasper holes 32 and 33. Although the device in FIG. 3 is shown using aduodenoscope as the endoscope 8, those skilled in the art willunderstand that other types of endoscopes may also be used, such as, forexample, gastroscope, colonoscope, etc.

As shown in FIG. 1, at least the distal end 12 a of the proximal housing12 preferably has a cross-section corresponding in size and shape to theproximal face 14 of the anvil member 10, including a cut-out 29substantially corresponding in size and shape to the cutout 13 of anvilmember 10. The cut-out 29 is provided to receive the endoscope 8 thereinand allow the proximal housing 12 to be slidably advanced along theendoscope 8. Of course, those skilled in the art will understand thatthe shape of the outer surface of the working head assembly 2 may beselected in order to accommodate various desired resectioning shapes,and the shape of the anvil member 10 may preferably be selected to forma continuous surface when positioned adjacent to the proximal housing 12to facilitate advancing the working head assembly to into and removingit from, body passages. It is preferable that the working head assemblyhave a maximum diameter at any point between 15 mm and 40 mm.

A tissue receiving cavity 30 is formed substantially centrally in thedistal end 12 a of the proximal housing 12 to facilitate the drawing ofsections of tubular organs into the gap between the anvil member 10 andthe distal end 12 a. Those skilled in the art will understand that thedepth of the cavity 30 may vary depending on the amount of tissue to bepulled into the cavity 30 and the size of the proximal housing 12. Twograsper holes 32 and 33 extend axially, preferably slightly off-centerfrom the longitudinal axis of the proximal housing 12. In a preferredembodiment, the grasper holes 32 and 33 may each preferably receive agrasping device 108 advanced from the control handle 6, through thesheath 4, and through a respective one of the grasped holes 32 and 33.

In operation, either one or two grasping devices 108 may then be used topull a section of the tubular organ between the anvil member 10 and thedistal end 12 a of the proximal housing 12 and into the cavity 30. Athird grasping device 108 may also be inserted through the workingchannel of the endoscope 8 to provide another means of positioning theorgan section between the anvil member 10 and the proximal housing 12.Of course, those skilled in the art will understand that any desiredinstrument may be advanced to the gap between the anvil member 10 andthe distal end 12 a through any of the grasped holes 32, 33 and theworking channel of the endoscope 8.

A plurality of staple slits 34 are preferably disposed in two offsetsubstantially circular rows extending along the periphery of the distalend 12 a of the proximal housing 12. The staple slits 34 extend from anarea adjacent to the mounting shaft 26 a to an area adjacent to theother mounting shaft 26 b. The plurality of staple slits 34 maypreferably be arranged so that when the anvil member 10 is in theproximal most position, each of the staple slits 34 is aligned with acorresponding one of the staple-forming grooves 19.

When the device is configured for operation, a plurality of staples isreceived within the working head assembly 2 with each of the staplesbeing aligned with a respective one of the staple slits 34. The staplesare then sequentially fired from the respective staple slits 34 by anactuating mechanism 104 (shown in FIG. 5) disposed in the proximalhousing 12.

A substantially circular blade slit 36 extends substantially radiallywithin the staple slits 34 so that, when the anvil is in the proximalmost position, the blade slit 36 is aligned with the guiding slit 21 onthe anvil member. As shown more clearly in FIG. 12, extensions 84 a and84 b of the blade slit 36 extend into blade housings 74 a and 74 b,respectively, which project distally from the distal end 12 a ofproximal housing 12. The blade housings 74 a and 74 b are preferablysituated so that when the anvil member 10 is in its proximal Mostposition, the blade housings 74 a and 74 b contact portions 43 a and 43b of the rim 41 of the anvil member 10. The extension of the bladehousings 74 a and 74 b from the proximal housing 12 is preferablyselected BO that when the blade housing devices 74 a and 74 b engage theremainder portions 43 a and 43 b of the rim 41 (thereby stopping aproximal movement of the anvil member 10 and defining the proximal mostposition thereof), a gap is formed between the anvil member 10 and thedistal end 12 a of a length sufficient to allow the anvil member 10 tosecurely hold a portion of the organ against the proximal housing 12without crushing and damaging the portion of the organ.

When positioned at one end of the blade slit 36 (i.e., in one of theextensions 84 a and 84 b), a cutting blade 202 is preferably completelyenclosed within the respective one of the blade housing devices 74 a and74 b and the guiding slit 21, so that the cutting blade 202 does not cutany tissue until the physician intentionally operates the blade 202.When the physician operates the blade 202, the blade 202 is driven fromits initial position received within one of the extensions 84 a and 84 baround the blade slit 36 with its cutting edge facing a direction ofmovement, until the blade 202 is received into the other one of theextensions 84 a and 84 b. Thus, after a cutting operation has beenperformed, the blade 202 is once again prevented from inadvertentlyinjuring the patient.

FIG. 6 shows a wedge 402, a first portion 402 a of which isnon-rotatably coupled to an actuating shaft 400 so that rotation of theshaft 400 the wedge 402 rotates, preferably about—the longitudinal axisof the working head assembly 2. The wedge 402 includes a blade handle408 which extends from a first portion 408 a coupled to the wedge 402 toa second portion 408 b which is coupled to the blade 202 so that, whenthe wedge 402 is rotated, the blade 202 is rotated through the bladeslit 36. The wedge 402 has a substantially bell-like cross-section whenviewed axially, with a second portion 402 b extending radially outwardfrom the first portion 402 a and, consequently, from the longitudinalaxis of the shaft 400 which preferably coincides with the longitudinalaxis of the working head assembly 2. A notch of varying depth is cut outof a radially outer portion of the second portion 402 b to form a camsurface 412 thereon. A first ramp section 412 a ramps up from a leadingface 402 d of the wedge 402 to adjoin a second ramp section 412 b thatramps down to adjoin a rear face 402 e of the wedge 402. The wedge 402is preferably arranged in the proximal housing 12 so that the camsurface 412 is substantially aligned with the staple slits 34.

A staple driver 472 extends substantially longitudinally, proximallyfrom each of the staple slits 34 having toward the plane in which thewedge 402 rotates and each staple driver 472 is slidably received withinthe working head assembly 2 for motion between a distal most, stapledriving position and a proximal most inoperative position. In theinoperative position, an upper end of each of the staple drivers 472 iscompletely received within the proximal housing 12, just proximal of arespective staple. The staple drivers 472 are preferably substantiallyrectangular in shape, although bottom edges 472 a thereof may morepreferably be rounded. The length of the staple drivers 472 ispreferably selected so that, in the inoperative position, the bottomsurfaces 472 a extend into the plane of rotation of the wedge betweenthe proximal and distal most extents of the first ramp portion 412 a.The bottom surfaces 472 a are, in the inoperative position, morepreferably substantially aligned with the distal most projection of theof the cam surface 412 at the leading face 402 d. Thus in operation, thewedge 402 is rotated by the actuating shaft 400 so that the first rampsection 412 a of the cam surface 412 successively drives each of thestaple drivers 472 into contact with a corresponding staple so that eachstaple driver 472 and its staple are driven distally through arespective one of the staple slits 34. This drives the staples acrossthe gap from the distal end 12 a into the anvil member 10, through anytissue held between the anvil member 10 and the proximal housing 12, andinto the corresponding staple forming grooves 19. Thus the section ofthe tissue gripped between the anvil member 10 and the proximal housing12 is stapled in a pattern substantially the same as that formed by thestaple slits 34 (i.e., substantially circular). At the same time, theblade 202 is rotated through the blade slit 36 to cut the tissue whichhas just been stapled through the rotation of the wedge 402.

After each of the plurality of staples has been fired, the wedge 402 maybe driven in a reverse direction to reload a new plurality of staples.The wedge 402 may rotate in a direction opposite the staple firingdirection without getting caught on any of the staple drivers 472because the staple drivers are pushed out of the way by the second rampsection 412 b of the cam surface 412.

In operation, the user applies a force to the control handle 6 to rotatean actuating cable 450 about its longitudinal axis. This rotationalforce is transferred to the actuating shaft 400, which then rotates thewedge 402 around the longitudinal axis of the actuating cable 450. Thefirst ramp section 412 a of the cam surface 412 of the wedge 402 thenindividually drives the staple drivers 472 distally as described aboveto staple the tissue received between the anvil member 10 and theproximal housing 12 with the cutting blade 202 lagging behind the firingof the stapling since the blade handle 408 is coupled to the rear face402 e of the wedge.

FIG. 10 a shows an alternative configuration of the wedge 402 of FIG. 6including a separate blade portion 420. The blade portion 420 ispreferably rotatably coupled to the distal end 400 a of the actuatingshaft 400 so that a rotation of the actuating shaft 400 about itslongitudinal axis does not cause a corresponding rotation of the bladeportion 420. As in FIG. 6, the wedge 202 of this apparatus isnon-rotatably coupled to the distal end 400 a of the shaft 400.

The blade handle 408 of this apparatus, which is coupled to a peripheraledge 420 e of the blade portion 420, extends to the cutting portion ofthe blade 202. As described above, the cutting portion of the blade 202extends past the distal end 12 a except when the blade 202 is receivedwithin one of the extensions 84 a and 84 b.

The wedge 402 substantially corresponds in shape and size to the wedge402 of FIG. 6, except that the blade handle 408 is not coupled thereto.In addition, a locking shaft 402 h extends into a distal surface 402 tlocated as shown in FIG. 10 a so that when the blade portion 420 and thewedge portion 410 are aligned, the locking shaft 402 h and a lockingdimple 414 (shown in FIG. 10 c) on the bottom face 420 b of the bladeportion 420 are substantially aligned. As shown in FIG. 10 b, a spring416 is received within the locking shaft 402 h with a proximal end ofthe spring coupled to the proximal end of the locking shaft 402 h. Alocking ball 418 coupled to the distal end 416 b of the spring 416 issized so that when a proximally directed force is applied to the lockingball 418, the locking ball 418 may be slidably received within thelocking shaft 402 h. In addition, when no distally directed force isapplied to the locking ball 418, the spring 416 preferably extends sothat approximately one half (or more) of the locking ball 418 extendsdistally out of the locking shaft 402 h. Thus, when the wedge 402 isrotated toward the blade portion 420, the locking ball 418 is receivedin a cut-out 425 formed on the proximal surface 420 b of the bladeportion 420. As shown in FIG. 10 c, the cut-out 425 slopes downward toadjoin the locking dimple 424 so that when the locking ball 418 isreceived, the slope of the cut-out 425 gradually pushes the locking ball418 into the locking shaft 420 h. Then, when the wedge 402 moves intoalignment with the blade portion 420, the locking ball 418 extends outof the locking shaft 402 h and enters the locking dimple 414 to couplethe wedge 402 to the blade portion 420 so that a rotation of the wedge402 causes a corresponding rotation of the blade portion 420.

A radial length B₁ between the peripheral edge 420 e of the bladeportion 420 and the actuating shaft 400 may substantially correspond toa radial length W₁ between the wall 402 f of the wedge portion 410 andthe actuating shaft. This places the blade handle 408 in substantiallythe same position, relative to the cam surface 402 c of the wedgeportion 410, as in the previous embodiments. Of course, those skilled inthe art will understand that it is important that the blade 408 shouldextend substantially distally to the blade slit 36 so that rotation ofthe blade portion 420 will cause a corresponding rotation of the blade202 through the blade slit 36.

In operation, the wedge 402 is initially situated distally of one of theblade housings, e.g., 74 a while the blade portion 420 is situateddistally of the blade housing 74 b with the blade 202 received in theblade housing 74 b. When the lesion tissue has been drawn into positionbetween the distal end 12 a and the anvil member 10, the physicianactuates the shaft 400 by applying a force at the control handle 6. Thiscauses the wedge portion 410 to rotate distally of the staple slits 34,to sequentially drive each of the staple drivers 472 distally throughthe corresponding staple slit 34. When the wedge 402 has rotated fullyinto alignment with the blade portion 420 and the locking ball 418 isreceived into the locking dimple 414, the operator then operates thecontrol handle 6 in the opposite direction to draw the blade 202 out ofthe blade housing 74 b to cut all of the tissue extending radiallyinward of the rows of staples. When the blade 202 is received in theother blade housing 74 a, the wall of the body passage is released andthe lesion tissue remains within the gap between the distal end 12 a andthe anvil member 10 held by the grasping devices 108. The lesion tissuemay then be withdrawn from the body for analysis. This embodiment of thewedge 402 provides a safeguard in case the stapling process must beprematurely aborted due to, for example, a jam in one of the stapleslits 34. Using this embodiment, the cutting process is not begun untilall of the staples have been fired. Thus, it is possible to reduce therisk of cutting an opening in an organ which is not completely closed bythe staples.

As shown in FIG. 5, the actuating mechanism 104 includes the actuatingcable 450 which extends from a proximal end 450 a coupled to the controlhandle 6 to a distal end 450 b coupled to the proximal end 400 a of theactuating shaft 400. Those skilled in the art will understand that thewedge 402 should preferably be situated towards the distal end 12 a ofthe proximal housing 12 so that the yoke 103 does not interfere withrotation of the wedge 402 around the longitudinal axis of the actuatingshaft 400 (discussed below) even when the yoke 103 is in its distal mostposition.

As shown in FIGS. 7-9 a, the rear cover plate 460 may preferably becoupled to the proximal end 12 b of the proximal housing 12. Theproximal end 12 b of the proximal housing 12 is then connected to thesheath 4. The actuating shaft 400 may preferably extend through a secondshaft hole 464 formed in the rear cover plate 460 of the proximalhousing 12 and preferably abuts an interior portion of the cavity 30provided on the proximal housing 12. An endoscope hole 466 maypreferably be provided on a portion of the rear cover plate 460 radiallyseparated from the longitudinal axis of the working head assembly 2 toguide the endoscope 8 into the cut-out 29 of the proximal housing 12.The endoscope 8 may preferably be received into the endoscope hole 466from an endoscope lumen 40 provided within the sheath 4 which ispreferably disposed along a periphery of the sheath.

FIG. 9 d shows a perspective cut-away view of the sheath 4 with thevarious devices (i.e., the two grasping devices 108, the drive cable100, the actuating cable 450, and the endoscope 8) extending therethrough. Each of the various devices are further enclosed by one of aplurality of tubes 510 which allow either a rotational movement (for thecables 100, 450) or a longitudinal (for the two grasping devices 108 andthe endoscope 8) movement therein. Similar to the sheath 4, theplurality of tubes extend from a proximal end coupled to the controlhandle 6, to a distal end coupled to the working head assembly 2. Theplurality of tubes 510 provide protection against damage due to, forexample, abrasion, and provide an isolated path through the sheath 4which prevents tangling between the various devices.

FIG. 18 shows a cross-section of the control handle 6 which may be usedin conjunction with a resectioning device of the invention. The controlhandle 6 may preferably be substantially “Y” shaped, with a first branch500 for operating the actuating mechanism 104 and a second branch 502for operating the drive mechanism 102 and a body 520. A receiving hole512 runs longitudinally through the center of the body 520 for receivingthe endoscope 8 there through. A first force transferring mechanism 504is coupled to an actuating control knob 508, and extends axially throughthe first branch 500, through the body 520, where it is coupled to theactuating cable 450 which extends through the sheath 4 to connect to theactuating mechanism 104. A second force transferring mechanism 506 iscoupled to a drive control knob 510, and extends axially through thesecond branch 502, through the body 520, where it is coupled to thedrive cable 100 which extends through the sheath 4 to the drivemechanism 102. Those skilled in the art will understand that the controlhandle may be designed in any variety of shapes to accommodate, forexample, different hand sizes, comfort, etc. In addition, differentforce transferring methods may also be used instead of a knob such as,for example, actuating levers, etc.

In operation, the user applies a rotational force to one of the controlknobs 508 and 510, the rotational force is transferred through arespective one of the force transferring mechanisms 504 and 506 whichthen transfers rotational force to a respective one of the drive cable100 and actuating cable 450, thereby operating the actuating mechanism104 or the drive mechanism 102 as described above.

FIG. 11 shows a device according to a second embodiment of the Presentinvention in which like reference numerals identify the same elements.

The anvil member 10 of this embodiment preferably has a substantiallycircular or elliptical cross-section and is gradually tapered from theproximal face 14 to its distal end 16, forming a bullet-like structure.This tapered shape allows the device to be more easily inserted into thepatient's body as the distal end 16 has a smaller cross-sectional sizethan in the first embodiment. Those skilled in the art will understandthat the anvil member 10 may have other tapered shapes besides abullet-like structure without departing from the scope of the presentinvention.

Instead of providing the cut-out 13 shown in the first embodiment toreceive the endoscope 8 therein, a substantially cylindrical firstendoscope lumen 13 extends axially through the center of the anvilmember 10. The distal end 16 of the anvil member 10 may preferably havea beveled edge 54 adjoining the first endoscope lumen 13 to allow for anexpanded field of forward vision via the endoscope 8.

The proximal housing 12 may preferably have a cross sectioncorresponding in size and shape to the cross section of the proximalface 14 of the anvil member 10 (i.e., substantially circular orelliptical). In this embodiment, the cavity 30 in the first embodimenthas been omitted and a substantially cylindrical second endoscope lumen52 extends axially through the center of the proximal housing 12.

However, as in the previous embodiment, two grasped holes 32, 33 extendaxially through the proximal housing. The two grasped holes 32 and 33may preferably be disposed between the mounting holes 26 a and 26 bsince the first endoscope lumen 13 now extends through the axial centerof the proximal housing 12. In addition, the grasped holes 32, 33 inthis embodiment may preferably have a substantially circularcross-section. However, those skilled in the art will understand thatthe cross-sectional shape of the grasped holes 32 and 33 may be selectedto, for example, accommodate another type of device.

A receiving sleeve 55 is provided on the proximal end 12 b of theproximal housing 12 for receiving the endoscope 8 and for guiding theendoscope 8 into the proximal housing 12. The receiving sleeve 55 maypreferably have a first section 56 and a second section 58. The firstsection 56 and second section 58 may preferably both have an annularcross-section forming a continuous center hole 59 there through. Thecenter hole 59 has a diameter which preferably corresponds to thediameter of the receiving hole 52 BO that the endoscope 8 may becontinuously received through the center hole 59 into the secondendoscope lumen 52 in the proximal housing 12. The second section 58preferably has a thicker wall than the first section 56, such that anannular ring formed by the cross-section of the second sections 58 has alarger width than an annular ring formed by the cross-section of thefirst section 56.

In contrast to the endoscope lumen 40 disposed along the periphery ofthe sheath 4 as shown in FIG. 1, the endoscope lumen 40 in thisembodiment preferably runs along an axial center of the sheath 4, sothat when the sheath 4 is coupled to the working head assembly 2, asubstantially continuously aligned path is formed through the centerhole 59, through the second endoscope lumen 52, and through the firstendoscope lumen 13. The actuating shafts 400 and 105 and the drivecables 450 and 102 are then located concentric to the endoscope lumen 40in the sheath 4.

FIG. 12 shows a device according to a third embodiment of the presentinvention. The proximal face 14 of the anvil member 10 of thisembodiment has a cross section similar to the crescent-shapedcross-section of the anvil member 10 of the device of FIG. 1. Thus, theanvil member 10 has two horns 22 a and 22 b formed on either side of acut-out 13 which extends axially through the anvil member 10 from theproximal face 14 to the distal end 15 to receive the endoscope 8therein. As with the device of FIG. 1, the cross-sectional size of theanvil member 10 diminishes in overall size from a maximum at theproximal face 14 to a minimum size at the distal end 15, and the horns22 a and 22 b become less pronounced from the proximal face 14 to thedistal end 15. In a side view, the anvil member 10 becomes graduallytapered from the proximal end 14 to the distal end 16.

As in the device of FIG. 11, the tapered shape of the anvil member 10 ofthe device of FIG. 12 allows for easier insertion of the device into thepatient's body. In contrast to the second embodiment, the cut-out 13provides a larger field of vision via the endoscope 8 as the anvilmember does not totally enclose the cut-out 13. And, as in the firstembodiment, two substantially cylindrical mounting shafts 20 a and 20 bare coupled to the proximal face 14 of the anvil member 10 on horns 22 aand 22 b and are received within the mounting holes 26 a and 26 b,respectively.

In contrast to the previous embodiments, the proximal housing 12 in thisembodiment may preferably have a substantially oval cross-sectionalshape. This shape of the proximal housing 12 is formed by extending theproximal housing 12 shown in FIG. 1 around the cutout 29 to create thesubstantially cylindrical second endoscope lumen 52. The oval shapeallows the second endoscope lumen 52 to be offset from the axial centerof the proximal housing 12 and aligned with the first endoscope lumen13. This offset of the second lumen 52 allows the cavity 30 to beprovided adjoining the blade slit 36. In all other material respects,the proximal housing 12 in this embodiment is substantially identical tothe proximal housing 12 illustrated in FIG. 1.

FIG. 13 shows a device according to a fourth embodiment of the presentinvention. This embodiment is substantially similar to the embodimentshown in FIG. 12. However, the proximal face 14 of the anvil member 10in this embodiment has a substantially oval-shaped cross sectioncorresponding to the proximal housing 12. The anvil member 10 is taperedtowards the distal end 16 to form a substantially bullet-like structurehaving an oval-shaped cross-section. The cut-out 13 shown in FIG. 12 maypreferably be enclosed within the anvil member 10 and thereby forms anextension of the first endoscope lumen 13.

A substantially semicircular shield 31 extends from the proximal face 14of the anvil member 10 and shields a hemispherical portion of the gapformed between the anvil member 10 and the proximal housing 12. Theshield 31 allows a tissue section to be drawn primarily in the gapbetween the staple-forming grooves 19 and the staple slits 34 withminimal spill-over into the rest of the gap.

A recessed groove 35 may preferably be formed around a portion of theproximal housing 12 for slidably receiving the shield 31 therein. Therecessed groove 35 may preferably have a size and shape substantiallycorresponding to the size and shape of the shield 31 so that when theanvil member 10 is in its proximal most position, the shield 31 isreceived within the recessed groove 35 to form a substantiallycompletely continuous outer surface of the proximal housing 12.

In operation, the user may utilize suction through the endoscope 8 todraw a tissue section into the gap between the anvil member 10 and theproximal housing 12. In such a situation, the shield 31 prevents aportion of the tissue section or loose debris from being pulled into thearea around the mounting shafts 20 a and 20 b which may otherwiseinterfere with the axial movement of the mounting shafts 20 a, 20 b. Inaddition, the shield 31 also serves to direct the pulling force of thesuction to pull tissue primarily in the gap between the staple forminggrooves 19 and the staple slits 34.

FIGS. 14 a and 14 b show a device according to a fifth embodiment of thepresent invention in which the working head assembly 2 is coupled to theendoscope 8 without the sheath 4. As described above, distal ends 500 aof control cables 500 (i.e., drive cable 100 and actuating cable 450)may preferably be coupled to the working head assembly 2 while proximalends 500 b of the control cables 500 are coupled to the control handle 6as in the previous embodiments. However, instead of using a flexiblesheath 4 to receive the control cables 500 and the endoscope 8, thecontrol cables 500 are inserted into respective tubes 510. Each of thetubes 510 should have a sufficient cross-section to allow the controlcables 500 to rotate within the tubes 510. The tubes 510 are thenfastened at various predetermined points along their lengths to theendoscope 8 by a plurality of fasteners 502. Those skilled in the artwill understand that many different types of fasteners may be usedeither alone or in combination for this purpose so long as the fastenersdo not impede the steering of the endoscope 8 or the rotation of thecables 500. Those skilled in the art will understand that tape (e.g.,surgical, electrical, etc.), electrical cable, rubber bands, otherbelt-style fasteners, etc. may be used as fasteners.

FIGS. 16-18 illustrate alternative configurations of the blade housing74 b and it will be understood that similar alternative embodiments maybe implemented for the blade housing 74 a.

The blade slit 36 continues through the blade housing 74 b into housingportion 84 b which extends from a forward end at which the blade slit 36enters the blade housing 74 b to a rearward end where the blade slit 36and the housing portion 84 b terminate. A shield receiving slit 480extends through the blade housing 74 b substantially perpendicular tothe housing portion 84 b between the forward and rearward ends thereof.

After an organ section has been stapled between the anvil member 10 andthe proximal housing 12, and the blade 202 is drawn through the stapledtissue, there may be a problem if tissue stretches along with the blade202 into the housing portion 84 b without being completely severed.Withdrawal of the resectioned tissue might then lead to tearing of thetissue which is to remain in place.

As seen in FIG. 17, a flexible breakaway shield 482 having a shape andsize substantially corresponding to the shape and size of the shieldreceiving slit 480 is inserted into the shield receiving slit 480. Afterentering the housing portion 84 b, the cutting blade 202 contacts theshield 482 and further progress of the blade 202 deforms the shield 482until the shield 482 is cut in half. When the shield 482 is cut in half,each half snaps back pulling the tissue in a direction opposite thedirection of travel of the blade allowing the cutting blade 202 tocompletely sever the tissue.

FIG. 18 shows a second alternative arrangement in which a flexible gate484, having a first gate half 484 a and a second gate half 484 b, may beremovably or fixedly mounted within the shield receiving slit 480. Eachof the halves 484 a and 484 b may preferably be mounted within arespective half of the shield receiving slit 480, so that a small gapformed there between substantially corresponds in width to the width ofthe cutting blade 202. The wiping action in a direction opposed to thedirection of travel of the blade 202 is substantially the same as thatof the shield 482 without requiring the severing and replacement of theshield 482 after each use.

FIGS. 19 a and 19 b show a third alternative arrangement in which a pairof tissue blockers 600 and 602 facilitate the cutting of the resectionedtissue. Although, the following discussion will focus on the firsttissue blocker 600, those skilled in the art will understand that asimilar arrangement may be provided on the second tissue blocker 602.

As shown in FIG. 19 a, the first tissue blocker 600 is composed of afirst rectangular bar 610 and a second rectangular bar 612 situated at afirst end 21 a of the guiding slit 21. The first rectangular bar 610 hasa first base 610 a and the second rectangular bar 612 has a second base612 a, which are both fixedly coupled to the proximal face 14 of theanvil member 10 and arranged so that the bases 610 a, 612 b straddleboth sides of the guiding slit 21 with a gap formed there betweencorresponding to the width of the guiding slit 21.

A first slot 614 a is provided in the first base 610 a of the firstrectangular bar 610, and a second slot 614 b is provided in the secondbase 612 a of the second rectangular bar 612 so that when therectangular bars 610, 612 are coupled to the anvil member 10, theflexible breakaway shield 482 (shown in FIG. 17) may be disposed withinthe slots 614 a, 614 b. As shown in FIG. 19 c, a pair of L-shaped holes620, 622 are provided on both ends of the blade slit 30 on the distalend 12 a of the proximal housing 12. The L-shaped holes 620, 622 extendlongitudinally within the proximal housing 12 to receive the rectangularbars 610, 612 therein when the anvil member 10 is coupled to theproximal housing 12.

This arrangement operates similarly to the arrangement shown in FIG. 17,so that the wiping action of the shield 482 in a direction opposite to amovement of the blade 202 allows the blade 202 to completely cut throughthe resectioned tissue. Although the shield 482 is initially a singlepiece in a first operation of the device, the shield 482 may be re-usedwithout replacement in further operations with minimal diminishment ofits effectiveness.

FIG. 20 shows a device according to a sixth embodiment of the presentinvention in which like reference numerals identify the same elements.The sheath 4 is substantially more rigid and shorter than in previousembodiments. Although this decreases the effective operative range ofthe device, the rigidity of the sheath 4 increases its overallstructural strength, allowing greater forces to be transferred therethrough to the working head assembly 2 than in the previous embodiments.The cables 100, 450 driving the various mechanisms 102, 104 may thenneed to be stronger and stiffer in order to accommodate the increasedforces. As a result of these changes, the overall size of the workinghead assembly 2 may then be increased to, for example, treat lesionsthat may be too large for the devices according to the previousembodiments to treat in a single procedure.

FIGS. 21-25 show a device according to a seventh embodiment of thepresent invention in which the working head assembly 2 comprises theanvil member 10, a stapler member 17, and a connecting adapter 25. Asshown in FIG. 21, the anvil member 10 and the stapler member 17preferably have substantially semi-circular shapes complementary to oneanother such that, when they are positioned adjacent to each other, theyform a substantially annular clamp-like device (as shown in FIG. 23).The anvil member 10 and the stapler member 17 are pivotally connectedvia a substantially cylindrical hinge-pin 60 which is provided on adistal end 25 a of the connecting adapter 25. A proximal end 25 b of theconnecting adapter 25 may preferably be coupled to the sheath 4 in amanner similar to that in which the proximal housing 12 is connected tothe sheath 4 in the previous embodiments. Those skilled in the art willunderstand that the shape of the anvil member 10 and the stapler member17 may be modified to accommodate specific needs or applications withoutdeparting from the scope of the present invention.

As shown in FIG. 22, a plurality of first ring-like extensions 10 b areformed on a first end 10 a of the anvil member 10. The first extensions10 b may preferably be separated a predetermined distance from oneanother to form a plurality of spaces in which a corresponding pluralityof second ring-like extensions 17 b formed on a first end 17 a of thestapler member 17 are accommodated. The first extensions 10 b maysubstantially correspond in shape and size to the second ring-likeextensions 17 b so that when the first anvil end 10 a and the firststapler end 17 a are engaged, an alternating arrangement of first andsecond extensions 10 b, 17 b is formed in which the holes of each of thefirst and second extensions 10 b, 17 b are substantially aligned to forma continuous hole in which a hinge-pin 60 is received. Thus, thehinge-pin 60 and the first and second extensions 10 b, 17 b form a hingewhich allows the anvil member 10 and the stapler member 17 to pivotabout the hinge-pin 60. A locking ring 62 may preferably be attached toa distal end 61 of the hinge-pin 60 to secure the first and secondextensions 10 b, 17 b to the hinge-pin 60.

A first anchoring joint 23 a is formed on an interior face 10 i of theanvil member 10. The first anchoring joint 23 a may preferably have asubstantially triangular cross-section viewed along the longitudinalaxis of the working head assembly 2. However, a side of the firstanchoring joint 23 a that is attached to the anvil member 10 maypreferably be convex in shape complementary to the concave shape of theinterior face 10 i of the anvil member 10. A substantially similarsecond anchoring joint 23 b is formed on an interior face 17 i of thestapler member 17 having a size and shape corresponding to the size andshape of the anchoring joint 23 a.

As shown in FIG. 23, first and second coupling elements 64 a, 64 b aredisposed on respective anchoring joints 23 a, 23 b to couple theanchoring joints 23 a, 23 b to two rod links 150 a, 150 b, respectively.The rod links 150 a, 150 b provide a rigid coupling between theanchoring joints 23 a, 23 b and a distal end 154 of a push rod 152.Thus, a longitudinal force in a distal or proximal direction applied tothe push rod 152 is transferred to the anchoring joints 23 a, 23 b, andthereby to the anvil member 10 and the stapler member 17.

In operation, when a distally directed pushing force is applied to thepush rod 152, the force is transferred through the link rods 150 a, 150b to the anvil member 10 and the stapler member 17 via the respectiveanchoring joints 23 a, 23 b, gradually separating an anvil head 10 c onthe anvil member 10 from a stapler head 17 c on the stapler member 17until they reach a tissue receiving position. Similarly, when aproximally directed pulling force is applied to the push rod 152, theanvil head 10 c and the stapler head 17 c are drawn toward one anotheruntil they reach a stapling position, in which the anvil head 10 c andthe stapler head 17 c are adjacent to one another separated by a narrowgap. As the anvil head 10 c and the staler head 17 c are drawn togetherby the push rod 152, a stabilizer tongue 308 extending from the staplerhead 17 c of the stapler member 17 is gradually received within astabilizing groove 304 on the anvil head 10 c. This tongue/groovearrangement provides a guide and a securing/stabilization mechanism forthe anvil member 10 and the stapling member 17.

The anvil head 10 c is disposed on a second end 10 e of the anvil member10 that is opposite to the first end 10 a thereof. The anvil head 10 cmay preferably have a substantially rectangular cross-section largerthan a cross-sectional size of the rest of the anvil member 10. Theanvil head 10 c has an anvil face 10 d on which a plurality ofstaple-forming grooves 19 may preferably be arranged in two offset,substantially straight lines. In addition, a substantially straightguiding slit 21 may preferably extend substantially along the center ofthe anvil face 10 d, substantially parallel to the lines ofstaple-forming grooves 19, while the stabilizing groove 304 ispreferably formed along a distal side of the anvil face 10 d forreceiving the stabilizer tongue 308. The stabilizing groove 304 maypreferably have a shape and size substantially corresponding to thestabilizing tongue 308 so that the stabilizing tongue 308 is snuglyreceived within the stabilizing groove 304 when the anvil member 10 andthe stapler member 17 are in the stapling position.

As shown in FIG. 23 a, the stapler head 17 c is formed on a second end17 e of the stapler member 17 opposite to the first end 17 a thereof,and preferably has a cross section corresponding, at least in the areaadjacent to a stapler face 17 d, to the size and shape of the anvil head10 c. A plurality of staple slits 34 are arranged on the stapler face 17d in positions corresponding to the position of the staple-forminggrooves 19 on the anvil head 10 c so that when the stapler face 17 d andanvil face 10 d are positioned adjacent to each other, each of theplurality of staple slits 34 is substantially aligned with acorresponding one of the plurality of staple forming groove 19.Additionally, a substantially straight blade slit 36 extends across thestapler face 17 d corresponding to the guiding slit 21 on the anvil head10 c so that when the stapler head 17 c and the anvil head 10 c arepositioned adjacent to one another, the blade slit 36 is substantiallyaligned with the guiding slit 21.

As shown in FIG. 23, the distal end 25 a of the connecting adapter 25preferably has a cross-section corresponding to the shape and size ofthe peripheral surface of the annular clamp-like shape formed by theanvil member 10 and the stapler member 17 so that a substantiallysmooth, continuous outer surface is formed by the anvil member 10, thestapler member 17, and the connecting adapter 25 when the anvil member10 and the stapler member 17 are in the stapling position. Theconnecting adapter 25 is preferably gradually tapered from the distalend 25 a to the proximal end 25 b thereof, and the proximal end 25 b maythen be coupled to the sheath 4 as shown in FIG. 24. As further shown inFIG. 24, a substantially cylindrical endoscope lumen 52 preferablyextends axially through the center of the connecting adapter 25 forreceiving a conventional endoscope 8 there through. The connectingadapter 25 may also have a substantially cylindrical rod hole 322extending axially along the periphery of the connecting adapter 25extending through an area adjacent to the hinge-pin 60, for receivingthe push rod 152 therein.

As shown in the cut-away view of FIG. 25, a track 350 is provided withinthe stapler head 17 c extending within the stapler head 17 c from anarea adjacent to a distal end 352 of the stapler head 17 c to an areaadjacent to a proximal end 354 thereof. FIG. 26 shows a cutaway view ofthe stapler head 17 c showing the track 350 having a substantiallyL-shaped cross-section. The track 350 may preferably be situated so thata first leg 350 a of the track 350 extends substantially beneath theplurality of staple slits 34 on the staple face 17 d, and a second leg350 b of the track 350 extends substantially beneath the blade slit 21on the staple face 17 d.

In a first configuration shown in FIG. 25, a wedgesled 402 is provided(instead of the wedge 402 described in the previous embodiments) on adistal end 350 a of the track 350. The wedge-sled 402 has a cut-out in acorner forming a cam surface 412 thereon and a blade handle 408. Thisprovides the wedge-sled 402 with a substantially L-shaped cross-sectionsubstantially corresponding to the cross-sectional shape of the track350. The wedge-sled 402 is arranged in the track 350 so that the camsurface 412 is substantially disposed in the first leg 350 a of thetrack facing toward the plurality of staple slits 34. Furthermore, thewedge-sled 402 is arranged in the track 350 so that the blade handle 408is substantially disposed in the second leg 350 b beneath the blade slit21. Thus, when the cutting blade 202 is coupled to the blade handle 408,the cutting blade 202 extends out of the blade slit 21 as in theprevious embodiments. As shown in FIG. 26, the stabilizing tongue 308has a receiving slit 309 for receiving the cutting blade 202 thereinwhen the wedgesled 402 is positioned at the distal end 350 a of thetrack 350. This prevents unintentional cutting of tissue as the deviceis inserted and guided within the organ.

As shown in FIG. 25, an actuating cable 450 for operating the staplerhead 17 c is coupled to the leading edge 402 d of the wedge-sled 402 andextends through the track 350, through a tube 332 (which is coupled tothe proximal end 354 of the stapler head 17 c and extends through thesheath 4 to the control handle) of the plurality of tubes 510 (shown inFIG. 9 d), and is then coupled to the control handle 6 (not shown).

In operation, the wedge-sled 402 is initially positioned at the distalend 350 a of the track 350 with the blade 202 received within thereceiving slit 309 of the stabilizing tongue 308 as the operatormaneuvers the device to a desired location within the body. While thedevice is being maneuvered to the desired location, the anvil member 10and the stapler member 17 are located adjacent to each other in thestapling position. When the desired position is reached, the operatorpushes the push rod 152 distally to separate the anvil member 10 and thestapler member 17 into the tissue receiving position. Then the operatordraws the portion of tissue to be resectioned into the gap between thestapler member 17 and the anvil member 10 and draws the push rod 152proximally to return the anvil member 10 and the stapler member 17 tothe stapling position, gripping the tissue to be resected within thegap. The operator then pulls actuating cable 459 proximally, drawing thewedge-sled 402 towards the proximal end 350 b of the track 350. As thecam surface 412 on the wedge-Bled passes beneath each one of theplurality of staple slits 34, the cam surface 412 drives each one of aplurality of staple drivers 472 (each being disposed within acorresponding one of the staple slits 34) sequentially driving aplurality of staples out of the staple slits 34 to staple the tissuegripped between the anvil head 10 c and the stapler head 17 c. Inaddition, the cutting blade 202 coupled to the blade handle 408 of thewedge-sled 402 is pulled through the blade slit 21 to resection thetissue which has now been stapled off from the organ.

When the tissue has been resectioned, the operator pushes the operatingcable 450 distally to return the cutting blade 202 to the receiving slit309 of the stabilizing wedge 308. The device may then be withdrawn fromthe body.

As shown in FIGS. 23 and 25, the anvil member 10 and the stapler member17 have a tissue receiving position shown in FIG. 25, and a staplingposition shown in FIG. 23. Therefore, it is necessary to allow theactuating cable 450 disposed within the tube 332 and received within thestapler head 17 c to correspondingly move with the stapler member 17.Accordingly, a channel 330 is provided in the connecting adapter 25 toreceive the tube 332 therein. The channel 330 may preferably be formedwithin the connecting adapter 25 to substantially correspond to the arcpath along which the tube 332 is pulled by the stapler member 17, as thestapler member 17 moves between the tissue receiving and the staplingpositions. Thus, the channel minimizes bending and crimping of the tube332.

Those skilled in the art will understand that although the proximalhousing 12 in any of the embodiments may preferably be composed of ametallic-type material, the proximal housing 12 may also be composed ofa clear plastic-type material which would allow the user to operate theworking head assembly 2 under visual observation by partiallywithdrawing the endoscope 8 into the second endoscope lumen 52 in theproximal housing 12. The user could then look through the walls of theendoscope lumen 52 into the proximal housing 12 to, for example, observewhether each of the plurality of staple drivers 472 have been actuated.In addition, the user may also observe whether the wedge 402 shown inFIGS. 10 a and 10 b is locked into the blade portion 420 as describedabove. Alternatively, selected portions of the proximal housing 12 maybe composed of the clear plastic-type material providing a “window” toview through the proximal housing 12.

Those skilled in the art will also understand that although theabove-described embodiments show mechanical force transmission betweenthe control handle and the working head assembly, this device couldalternatively include an electronic control for receiving input from anoperator coupled to a series of motors in the working head assembly.Those skilled in the art will further understand that the relativepositioning of the stapling mechanisms and the position adjustingmechanisms to each other may be reversed, placing the staplingmechanisms in a distal-most position in relation to the positionadjusting mechanism.

In a different embodiment, the FTRD according to the present inventionincludes a removable integrated surgical staple retainer that securesthe staples during shipping and can be used to gauge the outermostdiameter of an endoscope. The integrated surgical staple retainer ispreferably mounted between the proximal housing 12 and the anvil member10 of the FTRD when in position to retain the staples.

In one embodiment, shown in FIG. 27, the integrated surgical stapleretainer 623 can have a calibrating portion 624 and a retaining portion626. The calibrating portion 624 defines a circular opening 625 having adiameter substantially equal to a diameter of the working channel formedin the head assembly 2 of the full thickness resectioning device 628.The retaining portion 626 can have positioning elements that includeprotrusions such as ridges 627, which can be hollow, and which hold theintegrated surgical staple retainer 623 in position relative to the headassembly 2. In one exemplary embodiment, the integrated surgical stapleretainer 623 is placed between the proximal housing 12 and the anvilmember 10, which are then moved near one another. The ridges 627protrude behind the edge of anvil member 10, preventing removal of theintegrated surgical staple retainer 623. In an alternative embodiment,the retaining portion 626 can include a groove, a flat surface, or anyother feature to mechanically keep the integrated surgical stapleretainer 623 in place, instead of a plurality of hollow ridges.

The calibrating portion 624 can be located adjacent to, to either sideof, or behind the retaining portion 626 as long as the calibratingportion does not interfere with the retaining function. In oneembodiment of the present invention, the calibrating portion 624 can beinside the arc of the retaining portion 626. As seen in FIG. 28, inanother embodiment, the retaining portion 626 can be to the side of thecalibrating portion 624. The integrated surgical staple retainer 623 canalso have a grasping portion 630 which can be located adjacent to, toeither side of, in front, or behind the retaining or calibratingportion. As seen in FIG. 28, in one embodiment, the grasping portion 630is adjacent to the retaining portion 626 of the integrated surgicalstaple retainer opposite to the calibrating portion 624. An advantage ofthis particular embodiment is that the FTRD 628 does not need to beopened in order to remove and expose the calibrating portion 624. Theretaining portion 626 remains in place while the circular opening 625 isslid over the length of an endoscope 8 to gauge the diameter of theendoscope. In this manner, staples are less likely to fall Out ofhousing 12 while the device is being handled.

As shown in the exemplary embodiment of FIG. 29, in relation to the FTRD628, the retaining portion 626 of the integrated surgical stapleretainer 623 can be placed between the proximal housing 12 and the anvilmember 10 of the FTRD 628. In one embodiment, the integrated surgicalstaple retainer 623 can be placed between the staple slits 34 of theproximal housing 12 and the staple forming grooves 19 of the anvilmember 10. The calibrating portion 624 can be placed inside a cavitydefined by head assembly 2. Alternatively, the calibrating portion 624can extend outside of head assembly 2, or can be in any non-interferingposition.

As shown in FIG. 30, to use the retaining portion 626 of the integratedsurgical staple retainer 623, the distance 629 between the anvil member10 and the proximal member 12 is minimized such that the plurality ofridges 627 of the retaining portion 626 fill the staple forming grooves19 of the anvil member 10. Alternatively, ridges 627 are retained inplace by the circumference of anvil member 10. An underside surface 640of integrated surgical staple retainer 623 thus fully covers the stapleslits 34 of the proximal housing 12. In an alternative exemplaryembodiment, a flat surface of the retaining portion 626 contacts thestaple forming grooves 19 and also covers the staple slits 34. In thatcase, the integrated surgical staple retainer 623 can be held in placeby different shaped protrusions that engage the staple forming grooves19, or more generally, that engage the anvil member 10 so thatintegrated surgical staple retainer 623 remains in position relative tothe head assembly 2.

FIG. 31 shows the use of the calibrating portion 624 of the integratedsurgical staple retainer 623. The circular opening 625 is slid over thelength of an endoscope 8 to ensure a maximum diameter 630 never exceedsthe diameter of opening 625. If the entire endoscope 8 is able to slidethrough the circular opening 625, this indicates that the endoscope willbe able to slide through a working channel of the FTRD 628.

The use of the integrated surgical staple retainer according to thepresent invention includes, for example, the following steps. The FTRD628 is unpacked from its shipping package so that a user can hold thegrasping portion of the integrated surgical staple retainer 623 toremove it from between the proximal housing 12 and the anvil member 10of the FTRD. The user then slides the calibrating portion 624 of theintegrated surgical staple retainer along the length of an endoscope 8.If the endoscope 8 slides smoothly through the opening 625 of thecalibrating portion 624 of the integrated surgical staple retainer 623,the user has affirmative knowledge that the endoscope will be able toslide through the working channel of that FTRD 628 without binding, evenif the maximum diameter 630 is greater than a nominal diameter ofendoscope 8

Although the present invention has been described with respect toseveral exemplary embodiments, those skilled in the art will understandthat there are many other variations of the above described embodimentswithin the teaching of the present invention, which is to be limitedonly be the claims appended hereto.

1. A staple retainer for an endoscopic full thickness resection system,comprising: a retaining member including a positioning element which,when engaged by a corresponding structure in the full thicknessresection system maintains the retaining member in a predeterminedposition covering staple firing slits of a stapling mechanism of thefull thickness resection system to prevent surgical staples from beingdisplaced therefrom; a calibrating opening, a shape and size ofcalibrating opening corresponding to a shape and size of an endoscopereceiving lumen in the full thickness resection system for determiningwhether an endoscope is suitably sized to pass through the endoscopereceiving lumen; and a grasping portion connected to the retainingportion so that a user grasping the grasping portion may remove theretaining portion from the predetermined position to uncover the staplefiling slits of the full thickness resection system.
 2. The stapleretainer of claim 1, wherein the calibration opening is substantiallycircular.
 3. The staple retainer of claim 1, wherein the retainingportion comprises a plurality of protrusions that engage a correspondingstructure in the stapling mechanism to hold the staple retainer in thepredetermined position.
 4. The staple retainer of claim 3, wherein theprotrusions are formed as substantially hollow ridges.
 5. The stapleretainer of claim 1, wherein the retaining portion comprises a pluralityof grooves that engage a corresponding structure in the staplingmechanism to hold the staple retainer in the predetermined position. 6.A staple retainer for a system for full thickness resection of tissuefrom within a body, comprising: a substantially semi-circular retainingmember extending from a base, the base extending substantially within aplane perpendicular to the wall, wherein, when the surgical stapleretainer is in an operative configuration within a full thicknessresection system, the retaining member covers staple openings of astapling mechanism of the full thickness resection system; a calibratingopening formed in the retaining member, the calibrating opening having asize and shape corresponding to a size and shape of an endoscopereceiving lumen of the full thickness resection system; and a graspingportion coupled to the base so that a user may grasp the surgical stapleretainer thereby and withdraw the staple retainer from the operativeconfiguration to expose the staple openings for operation of the fullthickness resection system.
 7. The staple retainer of claim 6, wherein,when the staple retainer is in the operative configuration, thecalibrating opening extends outside the full-thickness resection system.